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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name condom
510(k) Number K082529
Device Name ALATECH CHAMPION VYTEX LUBRICATED MALE LATEX CONDOM
Applicant
ALATECH HEALTHCARE, LLC.
1600 STATE DOCKS RD.
eufaula,  AL  36027
Applicant Contact neil anderson
Correspondent
ALATECH HEALTHCARE, LLC.
1600 STATE DOCKS RD.
eufaula,  AL  36027
Correspondent Contact neil anderson
Regulation Number884.5300
Classification Product Code
HIS  
Date Received09/02/2008
Decision Date 05/01/2009
Decision substantially equivalent (SESE)
Regulation Medical Specialty Obstetrics/Gynecology
510k Review Panel Obstetrics/Gynecology
Type Abbreviated
Reviewed by Third Party No
Combination Product No
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